|Publication number||US7655047 B2|
|Application number||US 10/517,843|
|Publication date||Feb 2, 2010|
|Filing date||Apr 16, 2004|
|Priority date||Apr 16, 2003|
|Also published as||CN1777400A, CN100586401C, EP1613240A1, EP1613240A4, EP2308423A1, US8398720, US20050288790, US20100114316, WO2004093743A1|
|Publication number||10517843, 517843, PCT/2004/11903, PCT/US/2004/011903, PCT/US/2004/11903, PCT/US/4/011903, PCT/US/4/11903, PCT/US2004/011903, PCT/US2004/11903, PCT/US2004011903, PCT/US200411903, PCT/US4/011903, PCT/US4/11903, PCT/US4011903, PCT/US411903, US 7655047 B2, US 7655047B2, US-B2-7655047, US7655047 B2, US7655047B2|
|Original Assignee||Porex Surgical, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (91), Non-Patent Citations (37), Referenced by (9), Classifications (20), Legal Events (9) |
|External Links: USPTO, USPTO Assignment, Espacenet|
US 7655047 B2
A composite surgical implant that is made of a planar sheet of a thermoplastic resin that includes a top surface (400), a bottom surface (410), and a surgical grade metal mesh (405) contained therein. The implant may be bent by hand, wherein upon the displacement of the implant, the implant will generally maintain the shape to which it has been displaced.
1. A craniofacial implant comprising a porous polyethylene matrix and a surgical grade metal mesh embedded within the matrix such that the porous polyethylene matrix fills spaces within the mesh and encases the mesh such that all sides of the porous polyethylene matrix forming surfaces of the implant have pores that are sized between 20-500 microns, and wherein the implant is able to be bent or displaced by manipulation by hand such that the implant will generally maintain the shape to which it has been bent or displaced in a rigid and fixed position for attachment to bone, wherein the mesh provides a structure for attachment to bone.
2. The implant recited in claim 1, wherein the polyethylene matrix is porous throughout the implant.
3. The implant of claim 1, further comprising a structure for attachment to bone extending from the porous polyethylene matrix.
4. The implant of claim 3, wherein the structure for attachment to bone comprises a portion of mesh that extends beyond the encased mesh and the porous polyethylene matrix and is adapted to receive a surgical screw or surgical bone anchor.
5. The implant of claim 1, wherein the surgical grade metal mesh comprises titanium.
6. The implant of claim 1, wherein the porous polyethylene matrix comprises a high density polyethylene.
7. A craniofacial implant having a first surface and a second surface, the implant comprising a porous polyethylene matrix and a surgical grade metal mesh embedded within the matrix such that the porous polyethylene matrix fills spaces within the mesh and encases the mesh such that the second surface and sides of the porous polyethylene matrix have pores that are sized between 20-500 microns, wherein the first surface comprises a non-porous barrier surface of polyethylene, and wherein the implant is able to be bent or displaced by manipulation by hand such that the implant will generally maintain the shape to which it has been bent or displaced in a rigid and fixed position for attachment to bone, wherein the mesh provides a structure for attachment to bone.
8. The implant of claim 7, wherein the polyethylene matrix is porous throughout the matrix, and wherein the non-porous barrier surface of polyethylene is on the porous polyethylene matrix.
9. The implant of claim 7, further comprising a structure for attachment to bone extending from the porous polyethylene matrix.
10. The implant of claim 9, wherein the structure for attachment to bone comprises a portion of mesh that extends beyond the encased mesh and the porous polyethylene matrix and is adapted to receive a surgical screw or surgical bone anchor.
11. The implant of claim 7, wherein the surgical grade metal mesh comprises titanium.
12. The implant of claim 7, wherein the porous polyethylene matrix comprises a high density polyethylene.
The applicant claims the benefit U.S. Application Nos. 60/463,036 and 60/496,684.
BACKGROUND OF THE INVENTION
Craniofacial and especially orbital wall and floor defects may result from trauma, cancer, resection, or congenital defects. Such defects are typically treated surgically using bone grafts or synthetic implants. Congenital defects or fractures of the complex and relatively thin bone structures surrounding and supporting the human eye present difficult internal bone repair and fixation problems. In instances when the eye is subject to trauma, the margin or rim of the orbit may diffuse the force of the impact. However, compression of the orbital contents sometimes may occur and fracture the relatively fragile orbit floor and/or the lateral and medial orbital walls. Also injury at the lateral orbital rim may produce a fracture within the orbit. When the orbit is fractured standard bone-grafting techniques for orbital reconstruction may not result in predictable eye function and positioning. Often the support of the globe is deficient as a result of under correction of the defect, over correction, or inadequate reconstruction of the orbital volume. Further, the bone graph may be subject to resorption that may result in result in a less than optimal support. The accurate anatomical reconstruction of the bony orbit is essential to maintain normal function and appearance of the eye following orbital fractures. Because most of the bone of the internal orbit surfaces is thin, it is difficult to adequately stabilize the fractured bone fragments without the use of autogenous or alloplastic materials.
Autologous bone grafts have been considered an optimal treatment method for orbital floor and wall reconstruction. However, this material is sometimes difficult to obtain and difficult to shape the bone graft material to properly fit within the orbit. There are problems relating to the tissue donor site morbidity. As discussed above, autogenous bone grafts have frequently been used by craniomaxillofacial surgeons for the reconstruction of the internal orbit. Bone may be harvested from the calvarium and other autogenous materials including iliac bone, split rib bone. Cartilage has also been used as a bone graft material. However, autogenous bones sometimes result in an unacceptable amount of resorption.
A variety of alloplastic materials have been used for orbital reconstruction and craniofacial applications including, silicone rubber, Teflon, Supramid, tantalum mesh, Vitallium mesh, titanium mesh, polyethylene, and methyl methacrylate Perforated biocompatible metallic strips and metallic panels may be used for rigid internal fixation of fractures in trauma surgery and as a plate material for bone immobilization and stabilization. Metal implants can be used for bone graft support material in reconstructive surgery.
Synthetic implant materials have the advantage of no donor site morbidity, ease of use, relative low cost and ready availability. While there are advantages of synthetic implants, some characteristics may be regarded as disadvantages. Silicone rubber has a smooth surface, but does not allow fibrovascular ingrowth into the implant. Further, although it is flexible, it does not readily conform to the profile of the region where it is required or maintain a new shape when shaped to fit a particular location. For example, in connection with the reconstruction of the orbit, a silicone rubber implant is not an attractive option because upon shaping it to the desired profile, it will tend to be biased back to its original shape. While a silicone rubber implant does not maintain its shape, in a case where the soft tissues of the orbit have been traumatized, an implant with a smooth superior surface is desirable to prevent attachment of the tissues to the implant upon healing. Attachment of these tissues to the wall of the implant may result in restriction of movement of the eye, causing diplopia, dizziness, and headaches, as well as a cosmetic anomaly on upgaze, downgaze or lateral gaze.
Implants having a porous structure such as porous polyethylene with predetermined pore sizes allow for fibrovascular ingrowth. In some circumstances fibrovascular ingrowth is desirable because it integrates the implant within the tissues, and reduces the possibility that that the synthetic material will be rejected. Further, fibrovascular ingrowth on the inferior or sinus side of the implant, allows for mucosalization of the implant surface, and, since the opposite side of the implant may be a barrier, the sinus is effectively isolated from the soft tissues of the orbit. This arrangement is considered desirable because it increases the ability of the implant to ward off infection and minimizes the chance of a sinus infection from entering through the orbit. Fibrovascular ingrowth is also thought to minimize the chance of implant migration or displacement. Porous polyethylene is somewhat flexible and thin sheets appropriate for orbital floor and wall reconstruction can be bent to an appropriate shape. However, this material tends to return to its original shape. Further, porous polyethylene does not have a smooth superior surface, so it may result in restriction of the orbital tissues due to fibrous ingrowth when used for orbital reconstruction.
Pure titanium is the material of choice in craniofacial reconstructive surgery, especially when the implant is intended to be permanent. As an implant material, pure titanium is preferred because its low density and elastic modules are less than some of the stainless steel or cobalt-chromium alloys that have been used as implant materials. Titanium is corrosion resistant and, when provided in thin sheets, is pliable. Titanium implants many be cut and shaped to the appropriate configuration at the time of surgery. Titanium mesh is easily moldable in situ and easily fixed to bone, but does not have smooth surfaces, nor does it allow for fibrovascular ingrowth. An easily molded material is desirable so that the surgeon can create the correct shape to properly reconstruct the orbital walls or orbital floor. Titanium mesh can be molded to the desired shape by hand and it will retain the shape due to the malleability and strength of the titanium material.
While there are a number of options for an implant material for orbital reconstruction, there remains a need for a material that is easily moldable by hand and will retain its shape after molding, has a smooth impenetrable surface on one side, and a porous surface on the opposite side, and is made from highly biocompatible materials. Preferably it is desirable to provide an implant that can be trimmed and bent to shape to fit the shape of the orbital wall or orbital floor reconstruction, and placed in the orbit with the smooth surface on the inside, against the periosteum and soft tissues and with the porous side directed toward the sinus region. Further, it would be desirable to provide a material that can be fixed to the orbital bones with surgical screws or to the surrounding tissues with sutures.
It is an object of the present invention to provide a unique implant for the repair of orbital defects and fixation of orbital fractures.
It is a further object of the invention to provide a unique composite implant structure which can be shaped for use during a surgical procedures relating to the repair of the orbit and be readily cut, reshaped or bent to conform to the orbital walls and affixed to the orbit or the orbital margin.
It is another object of the invention to provide an implant structure that forms a barrier between the sinus and the soft tissues of the orbit.
It is a further object of the invention to provide a craniofacial implant that may be used in other applications wherein it is desirable to maintain the shape of the implant.
Other objects and advantages of the invention will be apparent from the following summary and detailed description of the orbital repair implant structure of the invention taken with the accompanying drawing figures.
SUMMARY OF THE INVENTION
The present invention is directed to an improved implant and method of reconstruction of craniofacial defects, and in particular for orbital defects. The implant is a composite structure comprised of a surgical grade metal provided in a planar sheet form that is encased within a thermoplastic resin. In a first embodiment, one surface of the implant is smooth and impervious so that when the implant is placed within the body, it may form a barrier. In an alternative embodiment of the invention, while one side of the implant has a smooth surface, the opposite side of the implant is comprised of porous polyethylene that allows for fibrous tissue ingrowth. In a method of reconstruction, the implant that is described herein is cut and then shaped to conform to the profile of a defect to be treated. The implant is then secured to bony tissue using surgical screws or an alternative mechanical fastener. Because the implant contains a mesh it will maintain its shape.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a top plan view of a first embodiment of an implant according to the invention wherein top side of the implant is a barrier surface.
FIG. 2 is a side view in elevation of the first embodiment of the invention showing the barrier surface and the bottom porous surface.
FIG. 3 is a bottom view of the first embodiment of the invention.
FIG. 4 is a perspective view of the first embodiment of the invention.
FIG. 5 is a side sectional view of an implant within a mold used to assemble the invention.
FIG. 6. is a top view of a mold depicted in FIG. 5 with the top cover removed.
FIG. 7 is a top view of an alternative mold that can be used to create the invention with the top cover removed.
FIG. 8 is a side sectional view of the mold depicted in FIG. 7
FIG. 9 is a top view of titanium mesh that may be employed with any of the embodiments of the invention.
FIG. 10 is an enlarged view of a section of the titanium mesh depicted in FIG. 9.
FIG. 11 is a side sectional view of an implant having opposite barrier surfaces that a center section.
FIG. 12 is a side view in elevation of the implant depicted in FIG. 11.
FIG. 13 is a side sectional view of the implant depicted in FIGS. 1-3.
FIG. 14 depicts a sectional view of a cranial defect.
FIG. 15 is a side sectional view of the implant shown in FIGS. 1-3 within a cranial defect.
FIG. 16 is yet another embodiment of the invention wherein the implant has opposite barrier surfaces.
FIG. 17 is a side view in elevation of the implant depicted in FIG. 16.
FIG. 18 is a side sectional view of a further embodiment of the invention wherein the metal mesh is formed with an implant with opposite porous surfaces.
FIG. 19 is an exploded view of an implant having three layers.
FIG. 20 is a perspective illustration of an implant according to the invention shown in an orbital reconstruction application.
DETAILED DESCRIPTION OF THE INVENTION AND THE PREFERRED EMBODIMENTS
The present invention is directed to novel implants for craniofacial surgery, methods for making said implant and a method of reconstructing orbital and cranial defects with the implants described. As described herein, a preferred application for the implant is for the reconstruction of orbital defects that may have resulted from trauma or disease or birth defects. Other craniofacial applications are also contemplated.
Now referring to FIG. 1, a first embodiment of the invention comprises a sheet of titanium mesh 20, with porous polyethylene formed in the interstices of the mesh and completely covering the bottom surface 27 of the implant. A solid sheet of polyethylene film 23 covers the top side of the implant. The mesh 20 provides for strength and serves to retain the shape of the implant in a rigid and fixed position. It should be understood that a mesh as used herein encompass any flat sheet of surgical grade metal that has perforations or passages formed through the sheet. The passages in the sheet help enable the sheet to be shaped or bent in more than one dimension and then retain the desired shape. It is contemplated that the mesh could be formed in a variety of manners including woven screens, or be etched from plates, or be formed from sold plates that are cut and then expanded to form a substrate having passages.
The first specific embodiment of the invention is illustrated in FIG. 1 where a smooth barrier material 23 lies on top of the titanium mesh material 20 with porous polyethylene 25 formed in the interstices and under the titanium mesh 20. As best seen in FIG. 4, the top surface 23 of the implant has some transparency so that the mesh 20 may be seen through the polyethylene film layer 23. While FIG. 1 shows the mesh 105 extended to the periphery of the implant, it is contemplated that in some embodiments the mesh may not extend to the edge of the implant structure. In yet other embodiments, the mesh may extend from the implant structure. In this later regard, it may be advantageous to extend the mesh from the implant structure to provide for a metal projection to be employed for the attachment of the implant during the surgical procedure. While in the embodiments depicted herein, the mesh is depicted in the center of the implant structure, it is contemplated that the mesh may be positioned adjacent to the top thin sheet layer or other locations within the implant depending on the respective application.
Now referring to FIG. 5, to manufacture the implant as depicted in FIG. 1, a mesh 40 is selected and positioned on tabs 50 that project form the sidewalls 45 and 48 of the bottom of the mold section 42. Next, polyethylene fines are introduced into the mold so that they fill the void below the mesh 40, the spaces between the titanium mesh 40 and cover the top surface of mesh 40. Last, a thin sheet or continuous film of solid polyethylene 55 is placed on the top of a suitable mold. The solid barrier sheet 55 extends beyond the edges of the cavity section of the mold and extends to the mold surface 63 thereby maintaining the sheet on one side of the mold.
FIG. 7 depicts an alternative arrangement for a mold wherein the mesh may be received on a shelf 70 that is suspended over the cavity using a shelf 70 around the mold cavity that holds the mesh sheet in position. As best seen in FIG. 8 shelf region 70 that extend into the void area 78 of mold 75 supports the edges of the mesh. A polyethylene sheet 90 is positioned above polyethylene fines 92 that fill the cavity 78. The passages through the mesh are identified by reference number 52. It should be understood that the dimensions, including the depth of the cavity from top surface 85 of bottom mold section 75, and the length and width of the mold may be altered depending on the particular application intended for the implant.
As illustrated by FIG. 8, the fines 92 come into contact with both the smooth polyethylene sheet 90 and the mesh 80. Once the mold is filled as described above, the top section 98 is placed over the components and the materials are subjected to heat and pressure, as is known in the current art, to form a porous polyethylene material. The heat and pressure causes the fines to be sintered together and to be affix the polyethylene sheet and titanium mesh. The resulting structure has titanium mesh embedded within a porous matrix and a solid smooth polyethylene film that is attached both to the titanium mesh and/or to the porous polyethylene structure. The sheet or film of polyethylene is impervious to water and serves as a barrier.
In a preferred embodiment of the invention described above, the polyethylene film is approximately 0.1 mm thick, the titanium mesh is approximately 0.35 mm thick, and the porous polyethylene is approximately 0.9 mm thick, inclusive of the embedded titanium mesh. Thus, the overall thickness of the material is approximately 1 mm.
Now referring to FIG. 13, a side sectional view of the implant depicted in FIGS. 1-4 shows the mesh 20 formed along the interface 175 between the porous layer and the solid polyethylene layer 23. As seen in FIG. 14, a defect in the cranium 178 has a floor 180 and a wall 182. In order to address this defect, the implant is bent to confirm to the contour of the defect and cut to the shape of the defect. The implant is placed within the defect and the implant to the bone using appropriately sized surgical screws. In the preferred embodiment of the invention, the titanium is of sufficient strength in relation to the thickness of the polyethylene components (the solid sheet and the porous matrix) so that the implant will hold its shape after being bent by the surgeon. It is therefore contemplated that during a surgical procedure the surgeon may bend the implant to conform to the shape of the defect that is being treated. In a preferred embodiment the surgeon can bend the implant by hand during the procedure. The implant as described above can also be cut with conventional plate cutters that are routinely used for cutting titanium surgical plates or mesh.
While preferred embodiments of the titanium mesh are illustrated by FIGS. 9 and 10, other titanium mesh products that can be used in connection with the invention are commercially available from sources that include Stryker Instruments, Synthes Maxillofacial, Leibinger, KLS-Martin, L. P. and Walter-Lorenz Surgical.
FIG. 11 depicts yet another embodiment of the invention in which the titanium 150 is placed between two opposite polyethylene barrier sheets 153 and 155. A porous matrix 160 is sandwiched between the barrier sheets 153 and 155. use. The configuration of this implant provides a bendable sheet that has a smooth polyethylene surface on both the top and bottom surface. The implant will retain its shape after it has been bent to conform to the contours of defect to be treated. The implant has strength properties that are inherent to titanium, and it has a non-porous barrier surface that is not amenable to tissue attachment to the implant. The thickness of the sheets of polyethylene may be selected to result in an implant having the desired thickness. In the alternative, the thickness of the implant may be adjusted by variation of the porous matrix layer 160. Like the previous embodiments, the implant may be bent by the surgeon and it will maintain its shape.
Now referring to FIG. 13, a side sectional view of the implant depicted in FIGS. 1-4 shows the mesh 20 formed along the interface 175 between the porous layer and the solid polyethylene layer 23. As seen in FIG. 14, a defect in the cranium 178 has a floor 180 and a wall 182. In order to address this defect, the implant is bent to conform to the contour of the defect and cut to the shape of the defect. The implant is placed within the defect and the bottom porous layer is brought into contact with the bone on the floor and sidewalls. The implant may be secured into place with screws or sutures. Because the bottom surface and the sidewalls of the implant are porous, fibrovascular ingrowth into the implant is encouraged, and this ingrowth serves to further stabilize the implant and diminish the possibility of rejection. The smooth barrier surface prevents the dermis from attachment and thereby allows the skin to slide over the implant area.
In yet a further alternative embodiment of the invention, the structure involves the providing of a titanium mesh plate within a porous polyethylene matrix wherein all sides have porous surfaces. FIG. 18 depicts a sectional view wherein the mesh 300 is formed with a porous polyethylene matrix. This implant may be suitable for those applications where a smooth barrier surface is not indicated. For example, an implant having porous surfaces that allow for fibrovascular ingrowth on opposite sides may be indicated in cranial applications and for temporal implants for soft tissue replacement.
In the preferred embodiments of the invention described above, the pore size of the porous polyethylene is sized large enough to allow for fibrovascular ingrowth. This pore size range would preferably be in the range of 100-250 microns, but could vary in the range of 20-500 microns. While polyethylene sheets and high density porous polyethylene matrix are preferred, it is also contemplated that other synthetic resins and combinations can be used in connection with the invention. For example PETE, PTFE and/or nylon may be selected as the thermoplastic resin. It is also should be understood that the Figures depicted herein are not necessarily drawn to scale. For example, the barrier in FIGS. 1-4 may be formed with a sheet having a much smaller width than the drawings may suggest. In a preferred embodiment the invention as depicted in FIGS. 1-4 is approximately 5 mm wide by 10 mm in length and has a thickness of approximately 1 mm. However, other dimensions are contemplated.
FIG. 5 is a sectional view of the implant according to one embodiment of the invention located within a mold. As depicted therein, the mesh is located adjacent to the barrier layer on the top of the mold. The barrier layer is formed of a solid sheet of polyethylene, and the porous section is made by sintering together polyethylene fines under heat and pressure. The solid sheet may be made by introducing polyethylene fines to a press having opposite smooth metal sheets and heating the surfaces causing the fines to completely fuse together. When the implant has cooled, the structure may be removed from the mold because the tabs 50 and implant materials have some flexibility.
Now referring to FIG. 6, a contemplated arrangement depicting a plurality of tabs 50 provided on the lower section of mold 61 is shown. The titanium sheet will rest on or is supported by the tabs 50 provided around the periphery of the mold. The tabs are placed a distance from the top surface of the mold that is slightly less than the width of the mesh, so that when the top of the mold that retains the barrier sheet is placed over the mold bottom, the thin barrier sheet may come into contact with the mesh. FIG. 7 depicts an alternative arrangement wherein the mold is provided with a shelf to retain the titanium mesh in position near the top of the mold.
FIG. 16 depicts yet a further embodiment of the implant wherein the top surface 214 and bottom surface 126 are polyethylene sheets. The mesh 220 is contiguous with the internal surfaces of both the top sheet 214 and the lower sheet 216. This implant has a top barrier surface 221 and bottom barrier surface 223 and is indicated in those applications where fibrovascular ingrowth is not desired.
FIG. 19 shows an exploded perspective schematic view of the embodiment according to the invention. Top layer 400 may comprise a barrier surface or porous surface. The mesh 405 may be any metallic material suitable for surgical applications that and that is malleable and will retain its shape. Bottom layer 410 may be a barrier surface or a porous surface. This embodiment depicts mesh 405 at the interface between the layers 400 and 410.
FIG. 20 depicts an implant 500 made according to the invention in position on the orbit floor of an orbit 507. In addition to the repair and reconstruction of orbital defects, the implants according to the invention may be advantageously employed with other surgery such as the repair of lost bone flaps resulting from neurological procedures, repair of the mastoid area after a mastoidectomy, fixation for LeFort procedures, fixation for sliding genioplasty. It is further contemplated that the planar sheets may be bent into tubular shapes and used for orthopedic applications. A planar sheet bent in a U shaped configuration may be useful in connection with spinal fixation procedures or the repair of herniated disks.
The invention having been described in detail with respect to preferred embodiments above, it will now be apparent from the foregoing to those skilled in the art that changes and modifications may be made without departing from the invention in its broader aspects, and the invention, therefore, as defined in the appended claims is intended to cover all such changes and modifications as fall within the true spirit of the invention.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4089071||Sep 8, 1976||May 16, 1978||Kalnberz Viktor Konstantinovic||Material for making bone endoprosthesis and endoprosthesis made of said material|
|US4164794||Apr 14, 1977||Aug 21, 1979||Union Carbide Corporation||Prosthetic devices having coatings of selected porous bioengineering thermoplastics|
|US4479271||Oct 26, 1981||Oct 30, 1984||Zimmer, Inc.||Tibial component for a knee joint prosthesis|
|US4502161||Aug 19, 1983||Mar 5, 1985||Wall W H||Prosthetic meniscus for the repair of joints|
|US4531916 *||Jul 8, 1983||Jul 30, 1985||W. L. Gore & Associates, Inc.||Dental implant with expanded PTFE gingival interface|
|US4693721||Apr 22, 1986||Sep 15, 1987||Paul Ducheyne||Porous flexible metal fiber material for surgical implantation|
|US4756862||Jun 23, 1986||Jul 12, 1988||Amoco Corporation||Sinterable thermoplastic resin; porosity, high strength|
|US4863474||Feb 23, 1988||Sep 5, 1989||Zimmer Limited||Skeletal implants|
|US4976738||Dec 2, 1985||Dec 11, 1990||Sulzer Brothers Limited||Porous metal overlay for an implant surface|
|US4978355||Jan 6, 1986||Dec 18, 1990||Sulzer Brothers Limited||Plastic bone implant having a reinforced contact surface|
|US5030233||Jul 17, 1987||Jul 9, 1991||Paul Ducheyne||Porous flexible metal fiber material for surgical implantation|
|US5139497||Nov 25, 1991||Aug 18, 1992||Timesh, Inc.||Orbital repair implant|
|US5250048||Jan 27, 1992||Oct 5, 1993||Ferdinand Gundolf||Stabilizing element for osteosynthesis of bone fragments, especially for the fixation of bone fractures|
|US5282861||Mar 11, 1992||Feb 1, 1994||Ultramet||Biocompatibility, lightweight, strong and porosity|
|US5290315||Dec 14, 1992||Mar 1, 1994||Joint Medical Products Corporation||Oblong acetabular cup|
|US5346492||Mar 9, 1993||Sep 13, 1994||Timesh, Inc.||Perforated metallic panels and strips for internal fixation of bone fractures and for reconstructive surgery|
|US5372598||May 14, 1992||Dec 13, 1994||Howmedica Gmbh||Small bone plate for cranial or facial fractures or the like|
|US5380328||Aug 9, 1993||Jan 10, 1995||Timesh, Inc.||Reconstructive surgery, cranial defects, layers of wire mesh and microporous membrane|
|US5383931||Jan 3, 1992||Jan 24, 1995||Synthes (U.S.A.)||Resorbable implantable device for the reconstruction of the orbit of the human skull|
|US5433996||Feb 18, 1993||Jul 18, 1995||W. L. Gore & Associates, Inc.||Laminated patch tissue repair sheet material|
|US5443512||Aug 24, 1993||Aug 22, 1995||Zimmer, Inc.||Orthopaedic implant device|
|US5443519||Apr 22, 1993||Aug 22, 1995||Implex Corporation||Prosthetic ellipsoidal acetabular cup|
|US5456723||Aug 17, 1992||Oct 10, 1995||Institut Straumann Ag||A screw having a rough porous surface by treating with a reducing acid for improving the bonding with the bones|
|US5468242||Nov 19, 1993||Nov 21, 1995||Leibinger Gmbh||Form-fitting mesh implant|
|US5489305||Oct 3, 1994||Feb 6, 1996||Timesh, Inc.||For mounting on the remaining stump portion of the ascending ramus|
|US5496372||Dec 1, 1993||Mar 5, 1996||Kyocera Corporation||Hard tissue prosthesis including porous thin metal sheets|
|US5545226||Apr 8, 1994||Aug 13, 1996||Porex Technologies Corp.||Implants for cranioplasty|
|US5669909||Mar 30, 1995||Sep 23, 1997||Danek Medical, Inc.||Interbody fusion device and method for restoration of normal spinal anatomy|
|US5690631||Sep 11, 1996||Nov 25, 1997||Walter Lorenz Surgical, Inc.||Multi-configurable plating system|
|US5743913||Apr 2, 1997||Apr 28, 1998||Wellisz; Tadeusz Z.||Surgical connector|
|US5755809||Sep 20, 1996||May 26, 1998||Implex Corporation||Femoral head core channel filling prothesis|
|US5766176||Sep 11, 1996||Jun 16, 1998||Walter Lorenz Surgical, Inc.||For use on osteosynthesis|
|US5769637||May 22, 1996||Jun 23, 1998||Sofamor Danek Properties, Inc.||Dental implant and alveolar process augmentation structures and method of installation|
|US5814048||May 3, 1996||Sep 29, 1998||Sofamor Danek Properties, Inc.||For use in the repair/recontour of large cranial defects in human skulls|
|US5824088||Feb 13, 1995||Oct 20, 1998||Kirsch; Axel||Cover device for bone voids and method for the manufacture thereof|
|US5980540||Apr 11, 1997||Nov 9, 1999||Kinamed, Inc.||Perforated cover for covering spaces in the cranium and conforming to the shape of the cranium|
|US5989427||Jul 17, 1997||Nov 23, 1999||Tetra Technologies, Inc.||Ceasing effluent flow from filter while maintaining influent flow, supplying backflushing water flow into bottom to release trapped gases without overflowing wier, ceasing backflushing and recommencing effluent flow|
|US5989472||Aug 20, 1997||Nov 23, 1999||Howmedica International, Inc.||Casting a metal backing including an attached mesh spaced away from front surface and a grill spaced away from rear surface, conformally molding a polymeric bearing material on rear face of metal backing thereby embedding grill|
|US6031148 *||Apr 2, 1993||Feb 29, 2000||W. L. Gore & Associates, Inc.||A multilayer medical article for the separation and regeneration of tissue|
|US6065197||Mar 1, 1999||May 23, 2000||Aichi Co., Ltd.||Method of spreading a sheet on a frame member and method of manufacturing a chair by the sheet spreading method|
|US6071291||Oct 21, 1998||Jun 6, 2000||Howmedica Leibinger Gmbh & Co. Kg (Leibinger)||Micro dynamic mesh|
|US6087553||Nov 6, 1997||Jul 11, 2000||Implex Corporation||Implantable metallic open-celled lattice/polyethylene composite material and devices|
|US6093188||Nov 10, 1997||Jul 25, 2000||Murray; William M.||Adjustable bone fixation plate|
|US6129728||Feb 18, 1998||Oct 10, 2000||Walter Lorenz Surgical, Inc.||Method and apparatus for mandibular osteosynthesis|
|US6143036||Jan 22, 1999||Nov 7, 2000||Comfort Biomedical, Inc.||Bone augmentation for prosthetic implants and the like|
|US6221075||Mar 6, 1998||Apr 24, 2001||Bionx Implants Oy||Bioabsorbable, deformable fixation plate|
|US6238214||Nov 20, 1998||May 29, 2001||Dane Q. Robinson||Guided tissue regeneration plate for use in a process for growing jaw bone in anticipation of performing dental implants|
|US6315798||Sep 17, 1999||Nov 13, 2001||Howmedica International S. De R.L.||Prosthetic implant attachment surface|
|US6325803||Sep 10, 1999||Dec 4, 2001||Walter Lorenz Surgical, Inc.||Method and apparatus for mandibular osteosynthesis|
|US6394807||Apr 10, 2001||May 28, 2002||Dane O. Robinson||Guided tissue regeneration plate for use in a process for growing jaw bone in anticipation of performing dental implants|
|US6620332||Dec 12, 2001||Sep 16, 2003||Tecomet, Inc.||Forming bone attachment device having screw holes and bend-able perforated mesh portions adjoining stiff, rigid rein-forcing plate portions|
|US6645250||Oct 30, 2001||Nov 11, 2003||Carl W. Schulter||Biocompatible form and method of fabrication|
|US6652585||Feb 19, 2002||Nov 25, 2003||Sdgi Holdings, Inc.||Flexible spine stabilization system|
|US6692497||Oct 6, 2000||Feb 17, 2004||Toermaelae Pertti||Bioabsorbable, deformable fixation plate|
|US6692498||Nov 27, 2000||Feb 17, 2004||Linvatec Corporation||Bioabsorbable, osteopromoting fixation plate|
|US6827743||Feb 25, 2002||Dec 7, 2004||Sdgi Holdings, Inc.||Woven orthopedic implants|
|US6852128||Oct 9, 2003||Feb 8, 2005||Sdgi Holdings, Inc.||Flexible spine stabilization systems|
|US20020050463||Sep 21, 2001||May 2, 2002||Mcdowell Christopher||Tray for surgical fastners|
|US20020120348 *||Dec 21, 2000||Aug 29, 2002||Melican Mora Carolynne||Reinforced tissue implants and methods of manufacture and use|
|US20020123750||Feb 25, 2002||Sep 5, 2002||Lukas Eisermann||Woven orthopedic implants|
|US20030208205||May 1, 2002||Nov 6, 2003||Jordan Medical Llc||Implantable device for covering and opening in a cranium|
|US20040054372||Jul 24, 2003||Mar 18, 2004||Btg International Limited||Transferring injection molding; shaping of polymer; blend of thermoplastic resin and fibers|
|US20040267349||Jun 27, 2003||Dec 30, 2004||Kobi Richter||Amorphous metal alloy medical devices|
|US20050043733||Jul 28, 2004||Feb 24, 2005||Lukas Eisermann||Woven orthopedic implants|
|US20050146070||Jun 10, 2003||Jul 7, 2005||Massachusetts General Hospital||Meta lback or mesh crosslinking|
|US20050288790||Apr 16, 2004||Dec 29, 2005||Porex Surgical, Inc||Craniofacial implant|
|US20060116682||Nov 16, 2005||Jun 1, 2006||Longo Marc N||Surgical implant and methods of making and using the same|
|US20060217813||Mar 22, 2006||Sep 28, 2006||Posnick Jeffrey C||Facial implant|
|US20060224242||Jun 2, 2006||Oct 5, 2006||Porex Surgical, Inc.||Craniofacial implant|
|US20070156146||Feb 16, 2006||Jul 5, 2007||Metzger Marc C||Implant for use as replacement of an orbita bottom|
|US20090138067||Oct 3, 2007||May 28, 2009||Leonard Pinchuk||Expandable supportive branched endoluminal grafts|
|CN1225373A||Feb 11, 1999||Aug 11, 1999||上海超高工程塑料有限公司||Polyethylene formation implant and method for making same|
|DE2404214A1||Jan 29, 1974||Aug 1, 1974||Louyot Comptoir Lyon Alemand||Knochenprothese|
|EP0092260A1||Apr 11, 1980||Oct 26, 1983||Kanebo, Ltd.||A composition of restorative material|
|EP0178650A2||Oct 16, 1985||Apr 23, 1986||Paul Ducheyne||Porous flexible metal fiber material for surgical implantation|
|EP0423420A2||May 2, 1990||Apr 24, 1991||Timesh, Inc.||Bone fracture reduction and fixation devices with identity tags|
|EP0433852A1||Dec 11, 1990||Jun 26, 1991||Leibinger GmbH||Grid for osteosynthesis or for attaching of artificial members of the body|
|EP0544384A2||May 11, 1992||Jun 2, 1993||TiMesh, Inc.||Orbital repair implant|
|EP0566255A1||Mar 22, 1993||Oct 20, 1993||TiMesh, Inc.||Perforated metallic panels and strips for internal fixation of bone fractures and for reconstructive surgery|
|EP0654250A1||Oct 13, 1994||May 24, 1995||Leibinger GmbH||Form-fitting mesh implant|
|EP0910993A2||Oct 13, 1998||Apr 28, 1999||Howmedica Leibinger GmbH & Co KG||Mesh for fixing bone fragments or for bridging bone defects|
|GB2059267A|| ||Title not available|
|JPH02237559A|| ||Title not available|
|JPH09173364A|| ||Title not available|
|JPH11155879A|| ||Title not available|
|WO1997041791A1||May 1, 1997||Nov 13, 1997||Sofamor Danek Properties Inc||Cranioplasty plates and method of installation|
|WO1999037240A2||Jan 22, 1999||Jul 29, 1999||Christopher J Calhoun||Resorbable, macro-porous, non-collapsing and flexible membrane barrier for skeletal repair and regeneration|
|WO2002092882A1||Apr 30, 2002||Nov 21, 2002||Mark P Amrich||Method for making a mesh-and-plate surgical implant|
|WO2003084410A1||Apr 1, 2003||Oct 16, 2003||Charles E Butler||Composite material for wound repair|
|WO2004093743A1||Apr 16, 2004||Nov 4, 2004||Porex Surgical Inc||Craniofacial implant|
|WO2007142743A2||Apr 18, 2007||Dec 13, 2007||Porex Surgical Inc||Craniofacial implant|
|1||First Examination Report for EP04759969.1 issued by the European Patent Office on Sep. 29, 2008.|
|2||Guarda-Nardini, Use of porous plyethylene (Medpor) iin maxillofacial surgery, Minerva Stomatol., 44(12):559-82 (1995) Abstract.|
|3||Helfen, et al., ‘Zementfreie Pfanne und zementierter Schaft-Konzept einger ,,Hybrid-Lösung sowie Ergebnisse einer drei- bis sechsjährigen klinischen Erfahrung,’ Z. Ortho., 131:578-584 (1993), Abstr.|
|4||Helfen, et al., 'Zementfreie Pfanne und zementierter Schaft-Konzept einger ,,Hybrid-Lösung sowie Ergebnisse einer drei- bis sechsjährigen klinischen Erfahrung,' Z. Ortho., 131:578-584 (1993), Abstr.|
|5||International Search Report for PCT/US07/009471 dated Aug. 8, 2008.|
|6||Janecka, I. P. "New Reconstructive Technologies in Skull Base Surgery", Archieves of Otolaryngology Head and Neck Surgery 2000 , vol. 126, 396-401.|
|7||Janecka, IP (2000): New reconstructive technologies in skull base surgery-Role of titanium mesh and porous polyethylene, Archives of Otolaryngology-head & Neck Surgery, 126 (3): 396-401 Mar. 2000.|
|8||Janecka, IP (2000): New reconstructive technologies in skull base surgery—Role of titanium mesh and porous polyethylene, Archives of Otolaryngology-head & Neck Surgery, 126 (3): 396-401 Mar. 2000.|
|9||Jones, et al., ‘Combined use of titanium mesh and biocompatible osteoconductive polymer in the treatment of full thickness calvarial defects,’ Br. J. Oral Maxillofac. Surg., 36(2):143-5 (1998) Abstract.|
|10||Jones, et al., 'Combined use of titanium mesh and biocompatible osteoconductive polymer in the treatment of full thickness calvarial defects,' Br. J. Oral Maxillofac. Surg., 36(2):143-5 (1998) Abstract.|
|11||Lara, et al., ‘Technical considerations in the use of polymethylmethacrylate in cranioplasty,’ J. Long Term Eff. Med. Implants, 8(1):43-53 (1998) Abstract.|
|12||Lara, et al., 'Technical considerations in the use of polymethylmethacrylate in cranioplasty,' J. Long Term Eff. Med. Implants, 8(1):43-53 (1998) Abstract.|
|13||Liu, James K., M.D., et al., Porous Polyethylene Implant for Cranioplasty and Skull Base Reconstruction. Medscape, Apr. 12, 2004.|
|14||Marbacher, S. et al., Primary Reconstruction of Open Depressed Skull Fractures With Titanium Mesh; The Journal of Craniofacial Surgery, vol. 19, No. 2, Mar. 2008, pp. 490-495.|
|15||MEDPOR Biomaterials brochure, 05 pages, Porex Surgical, Inc. (2004).|
|16||Moe, et al., ‘Resorbably fixation in facial plastic and head and neck reconstructive surgery: an initial report on polyactic acid implants,’ Laryngoscope, 111(10):1697-701 (2001) Abstract.|
|17||Moe, et al., 'Resorbably fixation in facial plastic and head and neck reconstructive surgery: an initial report on polyactic acid implants,' Laryngoscope, 111(10):1697-701 (2001) Abstract.|
|18||Moualt, ‘Acrylic cranioplasty and axial pattern flap following calvarial and cerebral mass excision in a dog,’ Aust. Vet. J., 80(4):211-5 (2002) Abstract.|
|19||Moualt, 'Acrylic cranioplasty and axial pattern flap following calvarial and cerebral mass excision in a dog,' Aust. Vet. J., 80(4):211-5 (2002) Abstract.|
|20||Murakami N., Saito N, Takahashi J., Ota H., et al. (2003): Repair of a proximal femoral bone defect in dogs using a porous surfaced prosthesis in combination with recombinant BMP-2 and a synthetic polymer carrier.|
|21||Murakami, N. Saito N., Horiuchi H., et al. (2002): Repair of segmental defects in rabbit humeri with titanium fiber mesh cylinders containing recombinant human bone morphogenetic protein-2 (rhBMP-2) and a synthetic polymer, J Biomed Mat Res, 62(2):169-174, Nov. 2002.|
|22||Office Action dated Nov. 12, 2009 issued in related U.S. Appl. No. 11/445,560.|
|23||Oka M., Ushio K., Kumar P., et al. (2000): Artifical Articular Cartilage, Proc Inst Mech Eng [H], 214(1):59-68,2000.|
|24||Park, Hun K., Biomechanical properties of high-density polyethylene for pterional prosthesis, http://findarticles.com, Neurological Research, Oct. 2002.|
|25||Roberson, et al., ‘Traumatic cranial defects reconstructed with the HTR-PMI cranioplastic implant,’ J. Craniomaxillofac. Trauma, 3(2):8-13 (1997) Abstract.|
|26||Roberson, et al., 'Traumatic cranial defects reconstructed with the HTR-PMI cranioplastic implant,' J. Craniomaxillofac. Trauma, 3(2):8-13 (1997) Abstract.|
|27||Supplementary Partial European Search Report from EP Appl. No. EP 04759969.1 issued May 2, 2008.|
|28||Temerkhanov, et al., ‘The use of titanium mesh plates for graft fixation in mandibular osteoplasty,’ Stomatologiia (Mosk), 77(6):31-3 (1998) Abstract.|
|29||Temerkhanov, et al., 'The use of titanium mesh plates for graft fixation in mandibular osteoplasty,' Stomatologiia (Mosk), 77(6):31-3 (1998) Abstract.|
|30||The Ahmed Glaucoma Valve, Ahmed website, 2004.|
|31||U.S. Appl. No. 11/445,560 Non-Final Office Action dated Oct. 29, 2008.|
|32||U.S. Appl. No. 11/445,560 Office Action dated May 9, 2008.|
|33||U.S. Appl. No. 11/445,560 Response to May 9, 2008 OA dated Jun. 2, 2008.|
|34||U.S. Appl. No. 11/445,560 Response to Office Action dated Dec. 23, 2008.|
|35||U.S. Appl. No. 11/445,560 Second Non-Final Office Action dated Mar. 17, 2009.|
|36||Wong, ‘Rigid mesh fixation for alloplastic cranioplasty,’ J. Craniofac. Surg., 5(4):265-9 (1994) Abstract.|
|37||Wong, 'Rigid mesh fixation for alloplastic cranioplasty,' J. Craniofac. Surg., 5(4):265-9 (1994) Abstract.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8231624||Dec 22, 2010||Jul 31, 2012||Strippgen Walter E||Dynamic surgical implant|
|US8281638 *||Apr 5, 2006||Oct 9, 2012||Synthes Usa, Llc||Method and apparatus for producing a planar implant for a human or animal body|
|US8298292||Jun 2, 2006||Oct 30, 2012||Howmedica Osteonics Corp.||Craniofacial implant|
|US8398720||Jan 6, 2010||Mar 19, 2013||Orthovita, Inc.||Craniofacial implant|
|US8608784||Jul 18, 2012||Dec 17, 2013||Walter E. Strippgen||Dynamic surgical implant|
|US8795377||Mar 10, 2011||Aug 5, 2014||Ossdsign Ab||Implants and methods for correcting tissue defects|
|US20110098760 *||Jan 6, 2011||Apr 28, 2011||Bryan Griffiths||Soft Tissue Spacer|
|US20130158670 *||Jul 29, 2011||Jun 20, 2013||The Henry M. Jackson Foundation For The Advancement Of Military Medicine, Inc.||Systems and methods for cranial implant assembly adapted for insertion during craniectomy procedure|
|WO2010099333A2||Feb 25, 2010||Sep 2, 2010||Porex Surgical, Inc.||Bone graft material containment structures|
| || |
|U.S. Classification||623/17.18, 623/17.19, 623/23.55, 623/23.54|
|International Classification||A61F2/30, A61F2/28, A61F2/00, A61B17/80, A61L27/44, A61F2/02|
|Cooperative Classification||A61F2250/0058, A61F2/30965, A61B17/8085, A61L27/446, A61F2002/30535, A61F2/2875|
|European Classification||A61L27/44R, A61F2/28S, A61B17/80P, A61F2/30M4|
|Mar 6, 2013||FPAY||Fee payment|
Year of fee payment: 4
|Dec 18, 2012||AS||Assignment|
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:HOWMEDICA OSTEONICS CORP.;REEL/FRAME:029582/0418
Effective date: 20121217
Owner name: ORTHOVITA, INC., PENNSYLVANIA
|Nov 23, 2010||CC||Certificate of correction|
|Nov 1, 2010||AS||Assignment|
Owner name: HOWMEDICA OSTEONICS CORP., NEW JERSEY
Effective date: 20101029
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:POREX SURGICAL, INC.;REEL/FRAME:025227/0255
|Oct 29, 2010||AS||Assignment|
Effective date: 20101029
Free format text: RELEASE OF PATENT SECURITY AGREEMENT;ASSIGNOR:GENERAL ELECTRIC CAPITAL CORPORATION, AS US AGENT;REEL/FRAME:025217/0801
Owner name: POREX SURGICAL, INC., GEORGIA
|Apr 5, 2010||AS||Assignment|
Owner name: GENERAL ELECTRIC CAPITAL CORPORATION, AS US AGENT,
Free format text: SECURITY AGREEMENT;ASSIGNOR:POREX SURGICAL, INC.;US-ASSIGNMENT DATABASE UPDATED:20100405;REEL/FRAME:24185/236
Effective date: 20100401
Free format text: SECURITY AGREEMENT;ASSIGNOR:POREX SURGICAL, INC.;US-ASSIGNMENT DATABASE UPDATED:20100513;REEL/FRAME:24185/236
Free format text: SECURITY AGREEMENT;ASSIGNOR:POREX SURGICAL, INC.;REEL/FRAME:024185/0236
|Apr 1, 2010||AS||Assignment|
Owner name: POREX CORPORATION,CALIFORNIA
Owner name: POREX HOLDING CORPORATION,CALIFORNIA
Owner name: POREX SURGICAL, INC.,CALIFORNIA
Free format text: RELEASE BY SECURED PARTY;ASSIGNOR:SNTC HOLDING, INC., AS COLLATERAL AGENT;US-ASSIGNMENT DATABASE UPDATED:20100401;REEL/FRAME:24170/471
Effective date: 20100401
Free format text: RELEASE BY SECURED PARTY;ASSIGNOR:SNTC HOLDING, INC., AS COLLATERAL AGENT;REEL/FRAME:024170/0471
Owner name: POREX CORPORATION, CALIFORNIA
Owner name: POREX HOLDING CORPORATION, CALIFORNIA
Owner name: POREX SURGICAL, INC., CALIFORNIA
|Oct 20, 2009||AS||Assignment|
Owner name: SNTC HOLDING INC., NEW JERSEY
Free format text: SECURITY AGREEMENT;ASSIGNORS:POREX HOLDING CORPORATION;POREX CORPORATON;POREX SURGICAL, INC.;REEL/FRAME:023390/0702
Effective date: 20091019
Owner name: SNTC HOLDING INC.,NEW JERSEY
Free format text: SECURITY AGREEMENT;ASSIGNORS:POREX HOLDING CORPORATION;POREX CORPORATON;POREX SURGICAL, INC.;US-ASSIGNMENT DATABASE UPDATED:20100203;REEL/FRAME:23390/702
Free format text: SECURITY AGREEMENT;ASSIGNORS:POREX HOLDING CORPORATION;POREX CORPORATON;POREX SURGICAL, INC.;US-ASSIGNMENT DATABASE UPDATED:20100309;REEL/FRAME:23390/702
Free format text: SECURITY AGREEMENT;ASSIGNORS:POREX HOLDING CORPORATION;POREX CORPORATON;POREX SURGICAL, INC.;US-ASSIGNMENT DATABASE UPDATED:20100318;REEL/FRAME:23390/702
|Jul 12, 2005||AS||Assignment|
Owner name: POREX SURGICAL, INC., GEORGIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SWORDS, GREG;REEL/FRAME:016874/0759
Effective date: 20050315
Owner name: POREX SURGICAL, INC.,GEORGIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SWORDS, GREG;US-ASSIGNMENT DATABASE UPDATED:20100203;REEL/FRAME:16874/759